Banerjee, Kalyan
Kakkar, Ajay
Shamsi, Kashif Ahmed
Bansal, Deepak
Mathur, Priyesh
Potode, Nitin Madan
Pagariya, Pankaj
Azher, Sha Perveez
Chaudhari, Apurva
Mandal, Ritu
Karadkhele, Archana S. http://orcid.org/0000-0003-4727-487X
Markandeywar, Neeraj
Dharmadhikari, Shruti
Khandhedia, Chintan
Mane, Amey
Mehta, Suyog
Joglekar, Sadhna
Funding for this research was provided by:
Sun Pharma
Article History
Accepted: 8 November 2023
First Online: 18 December 2023
Declarations
:
: The authors KB, AK, KAS, DB, PM, NMP, PP, SPA, AC, and RNM declare no conflict of interest. The authors ASK, NM, SD, CK, AM, SM, and SJ are employees of Sun Pharmaceutical Industries Ltd., Mumbai, India, who sponsored the study. Author, SJ was affiliated with Sun Pharmaceutical Industries Ltd., Mumbai, India, as Senior Vice President and Head- Global Medical Affairs and Clinical Research during the study execution.
: The written and dated approval from the institutional ethics committee (IEC) was taken as per Sekhmetâs (THB) ethical committee submission standard operating procedure (SOP). The study was approved by the Royal Pune Independent Ethics Committee (RPIEC) located in Pune, India (Ethics Approval Number: RPIEC090223; dated 7th Feb 2023).
: This retrospective real-world study was conducted using anonymized data (existing medical records that are available as of the date of IEC submission) without any additional prospective components for research purposes. Hence, the process did not necessitate obtaining informed consent since the study did not involve identifiable individuals. Accordingly, permission for the ICF waiver was obtained as per the ICMR Guidelines for Biomedical Research 2017 from RPIEC before initiating the data collection process for this study.
: Not applicable.